-
Fudan-Zhangjiang Bio-Pharmaceutical Advances Aminolevulinic Acid Study for Glioma Visualization
•
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the first subject has been enrolled in a confirmatory clinical study for its aminolevulinic acid used in the intraoperative visualization of advanced gliomas. This development comes as the company seeks to enhance surgical outcomes for patients with this…
-
AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
•
AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
-
Kintor Pharmaceutical Initiates Phase II Clinical Trial for Acne Treatment GT20029 in China
•
Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its drug candidate GT20029, which is being investigated for the treatment of acne in China. The Phase II study is a multi-center, randomized, double-blinded,…
-
RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
•
RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
-
Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Breast Cancer Drug Combo
•
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
-
Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
•
Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
-
Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
-
Haisco Pharmaceutical’s BRAF Inhibitor HSK42360 Gains NMPA Approval for Clinical Trials
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that it has secured another clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK42360. This BRAF V600 inhibitor is now poised to be evaluated in clinical trials for…
-
AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
•
The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by AbbVie Inc. (NYSE: ABBV) and Calico Life Sciences, into its Rare Disease Therapy Pilot Program. The investigational eIF2B activator is currently undergoing a Phase Ib/II clinical trial for the treatment of vanishing white matter (VWM)…
-
SinoMab BioScience’s SM17 Atopic Dermatitis Drug Reaches First Patient Milestone in Phase Ib Trial
•
SinoMab BioScience Ltd (HKG: 3681), a biotech firm based in Hong Kong, has announced the first patient dosing in a Phase Ib clinical study for SM17, a pioneering drug for atopic dermatitis (AD). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SM17, along with preliminary efficacy,…
-
Ascentage Pharma Gets Green Light for Global Phase III Trial of Olverembatinib in SDH-Deficient GIST
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a global regulatory Phase III study for its Category 1 drug olverembatinib. The study aims to evaluate the efficacy of olverembatinib in…
-
InnoCare Pharma’s TYK2 Inhibitor ICP-332 Receives FDA IND Approval for Atopic Dermatitis
•
InnoCare Pharma (HKG: 9969, SHA: 688428), a biopharmaceutical company based in China has announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its TYK2 inhibitor, ICP-332. This development marks a significant step forward for the company as it seeks to expand its…
-
AI-Powered Biotech Insilico Medicine Initiates Phase I Clinical Trial for Inflammatory Bowel Disease Drug
•
Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that the first patient has been dosed in a Phase I clinical study for its candidate drug ISM5411. This follows the drug’s initial entry into clinical studies in Australia. ISM5411 is an orally administered…
-
HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
•
HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
-
Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
-
Olymvax Bio Receives Ethical Approval for Oral Helicobacter pylori Vaccine Trial in Australia
•
Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received ethical approval for a Phase I study for its oral recombinant Helicobacter pylori (HP) vaccine (Escherichia coli) in Australia. The company has completed the clinical trial filing for this proprietary product.…
-
Sanofi Receives NMPA Approval for Phase III Clinical Trial of RSV Vaccine SP0125
•
Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children. RSV is among the most…
-
Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
•
Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
-
ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of Timdarpacept in CMML
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). IMM01 is an SIRPαFc fusion protein that is being studied for use in combination with…
-
Hengrui Pharmaceuticals Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
